CLA-2 CO:R:C:M 089937 KCC
Michael K. Tomenga, Esq.
McKenna & Cuneo
1575 Eye Street, N.W.
Washington, D.C. 20005
RE: Aerosol Therapy Device; GRI 1; EN 90.19; Note 2(b), Chapter
90; apparatus
Dear Mr. Tomenga:
This is in response to your letter dated July 16, 1991, on
behalf of Monaghan Medical Corporation, concerning the tariff
classification of an aerosol therapy device under the Harmonized
Tariff Schedule of the United States Annotated (HTSUSA).
FACTS:
The merchandise under consideration is an aerosol therapy
device called the Aerochamber. The Aerochamber is a FDA-
approved medical device that is used with a metered dose inhaler
("MDI") to deliver aerosol medication to asthma patients. The
Aerochamber is in the shape of a tube measuring approximately 4
1/4 inches in length and 1 5/8 inches in diameter. The device
acts as a temporary holding chamber for MDI-dispersed medication.
At one end of the holding chamber is a plastic mouthpiece
containing a one-way silicone inhalation "flapper" valve and
exhalation ports. At the other end of the device is a rubber end
cap with a port into which a standard MDI may be inserted.
Imbedded in the rim of the end cap is a Flowsignal, a plastic
whistle-like device. Except for the rubber port and silicone
flapper valve, the Aerochamber is made entirely of medical grade
plastic.
The patient uses the Aerochamber as follows: the patient
inserts the MDI into the port end of the Aerochamber, shakes the
entire apparatus, depresses the MDI cartridge to spray a measured
amount of aerosol medication into the Aerochamber holding
chamber, and slowly and evenly inhales the medication from the
holding chamber through the Aerochamber mouthpiece. The
medication is held in the Aerochamber holding chamber for a short
period, which allows the patient a delay between firing the MDI
and inhalation of the medication. If the patient attempts to
inhale the aerosol medication too quickly, the Aerochamber
flowsignal will sound, warning the patient to inhale more slowly.
ISSUE:
What is the proper tariff classification of the aerosol
therapy device under the HTSUSA?
LAW AND ANALYSIS:
The classification of merchandise under the HTSUSA is
governed by the General Rules of Interpretation (GRI's). GRI 1,
HTSUSA, states in part that "for legal purposes, classification
shall be determined according to the terms of the headings and
any relative section or chapter notes...."
Subheading 9019.20.00, HTSUSA, provides for "Mechano-therapy
appliances; massage apparatus; psychological aptitude-testing
apparatus; ozone therapy, oxygen therapy, aerosol therapy,
artificial respiration or other therapeutic respiration
apparatus; parts and accessories thereof...Ozone therapy, oxygen
therapy, aerosol therapy, artificial respiration or other
therapeutic respiration apparatus; parts and accessories thereof"
(emphasis added). Explanatory Note (EN) 90.19 of the Harmonized
Description and Coding System (HCDCS) states that an "aerosol
therapy apparatus" is "used for the application of a therapeutic
agent in the treatment of pulmonary, cutaneous, oto-rhino-
laryngologic, gynaecologic diseases, etc., by the dispersion
(nebulisation) in the form of a mist of various medicinal
solutions (hormones, vitamins, antibiotics, broncho-dilating
preparations, essential oils, etc.). Some of these appliances
are of the individual type (nebulisers) designed for connecting
to cylinders of oxygen or compressed air...." HCDCS, EN 90.19,
Vol. 4, p. 1495. The Explanatory Notes, although not
dispositive, are to be looked to for the proper interpretation of
the HTSUSA. 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The MDI, to which the Aerochamber is attached, meets the
definition of an "aerosol therapy apparatus" in EN 90.19. An MDI
is a device used by asthma patients to disperse or nebulize a
liquid medicinal solution contained in an attached aerosol can
(commonly a mast cell membrane stabilizer, steroid or
bronchodilator) into the lungs in a mist form for the treatment
of their disease. The MDI performs exactly the same function as
the nebulizer described in EN 90.19.
In 1987, the Harmonized System Committee decided to include
in the Harmonized Compendium of Classification Opinions a
classification opinion written under the Customs Cooperation
Council Nomenclature for applicability under the Harmonized
System. This classification opinion held that a metered dose
inhaler-like device is classifiable under subheading 9010.20,
HTSUSA. The ruling specifically states that "aerosol therapy
apparatus" encompasses:
an aerosol-type hand-spray, for use by a dentist or by
the patient himself to spray the teeth or gums. The
spray operates by means of compressed gas (e.g. CO2)
contained in a screw-on cartridge; the action of the
medicinal substance used and the massage resulting from
spraying the mucous membranes clears the mouth and
treats certain diseases (e.g. periodontitis).
Similarly to the Explanatory Notes, the issuance of a
classification opinion in the Compendium Classification Opinions
constitute the Customs Cooperation Council's (CCC) official
interpretation of the Harmonized System. Although generally
indicative of the proper interpretation of the various
provisions, they are not legally binding on the contracting
parties. Thus, while they should be consulted for guidance,
these documents should not be treated as dispositive. T.D. 89-
90, 23 Cust. Bull. 36 (1989), and 54 Fed. Reg. 35127, 35128
(August 23, 1989).
We are of the opinion that the operation described in the
Compendium Classification Opinion concerning the "metered dose
inhaler-like device" is similar to the operation of the device in
this case. The device in the CCC opinion that generates an
aerosol-type spray by means of a compressed gas contained in a
fluorocarbon-pressurized cartridge. The only distinction between
the two devices seems to be that the MDI-generated medication is
intended for treatment of a disease of the lungs rather than the
diseases of the mouth.
Pursuant to Note 2(b), Chapter 90, HTSUSA, parts and
accessories of apparatus, "...if suitable for use solely or
principally with a particular kind of machine, instrument or
apparatus, or with a number of machines, instruments or apparatus
of the same heading (including a machine, instrument or apparatus
of heading 9010, 9013 or 9031) are to be classified with the
machine, instruments or apparatus of that kind." The Aerochamber
is used solely with an aerosol therapy apparatus, an MDI. The
Aerochamber is designed and marketed to be used exclusively with
an MDI. The rubber port end of the device contains an opening
which is designed to be fitted to an MDI and no other device.
The sole function of the Aerochamber is to improve the
application and enhance the therapeutic value of the MDI-
generated aerosol therapy solutions. The Aerochamber was
specifically developed to assist patients in coordinating
discharge of aerosol medication from the MDI with proper
inhalation, as well as to eliminate harmful side effects that
result from discharge of the MDI directly into the patient's
mouth. As the Aerochamber is designed for and specifically used
with an aerosol therapy apparatus, it is classified under
subheading 9019.20.00, HTSUSA.
HOLDING:
The Aerochamber is properly classified under subheading
9019.20.00, HTSUSA, as "Mechano-therapy appliances; massage
apparatus; psychological aptitude-testing apparatus; ozone
therapy, oxygen therapy, aerosol therapy, artificial respiration
or other therapeutic respiration apparatus; parts and accessories
thereof...Ozone therapy, oxygen therapy, aerosol therapy,
artificial respiration or other therapeutic respiration
apparatus; parts and accessories thereof."
Sincerely,
John Durant, Director
Commercial Rulings Division